NCT06190535

Can Administration of Etamsylate Reduce Postpancreatectomy Hemorrhage

Doses Systematic Per Oral Administration of Etamsylate Can Reduce Postpancreatectomy Hemorrhage From Pancreatic Stump in Pancreatogastrostomy

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: University of Sfax · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

In several studies comparing the tow types of pancreato-digestive anastomosis: pancreatogastrostomy (PG) and pancreatojejunostomy (PJ), authors concluded that PG exposed to more postpancreatectomy hemorrhage (PPH) especially early, digestive and moderate hemorrhage classified as type A according to the classification of the ISGPS. In this way we try to test the ability of the enteral administration through the nasogastric tube of Etamsylate for 48 hours after Whipple to reduce the rate of digestive PPH and mortality.

Detailed description

Whipple procedure is usually performed for periampullary malignancies. If the mortality of this intervention has been markedly decreased, it persists a morbid one. Morbidity is mainly due to postoperative leak of the pancreato-digestive anastomosis or postoperative pancreatic fistula (POPF), but also to postpancreatectomy hemorrhage (PPH). In several studies comparing the tow types of pancreato-digestive anastomosis: pancreatogastrostomy (PG) and pancreatojejunostomy (PJ), authors concluded that PG exposed to more postpancreatectomy hemorrhage (PPH) especially early, digestive and moderate hemorrhage classified as type A according to the classification of the ISGPS. In this case of hemorrhage, blood generally comes from pancreatic stump which is anastomosed or telescoped in the stomac. Incomplete hemostasis , soft pancreatic tissue and vascular fragility can help PPH to occur. Etamsylate is an antihemorrhagic agent which works by increasing the resistance in the endothelium of capillaries and stimulating platelet adhesion. It also inhibits synthesis and action of prostaglandins causing platelet disaggregation, vasodilation and increased capillary permeability. In this way, the investigators try to test the ability of the enteral administration through the nasogastric tube of Etamsylate for 48 hours after Whipple to reduce the rate of digestive PPH and mortality.

Conditions

• Postpancreatectomy Hemorrhage

Interventions

Type	Name	Description
DRUG	Etamsylate	Enteral administration of Etamsylate as solution galenic form

Timeline

• Start date: 2024-01-01
• Primary completion: 2024-12-31
• Completion: 2025-03-30
• First posted: 2024-01-05
• Last updated: 2024-01-05

Locations

1 site across 1 country: Tunisia